[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644942":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":25,"centralContacts":26,"locations":36,"responsibleParty":55,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":25,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":88,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pulsed-Field Ablation Group","EXPERIMENTAL","Subjects with persistent atrial fibrillation undergoing the index ablation procedure with pulsed-field ablation (PFA) for pulmonary vein isolation and posterior wall isolation, with additional substrate modification at the operator's discretion. The procedure is performed under deep sedation or general anesthesia using the FARAWAVE Catheter, FARADRIVE Catheter, and FARASTAR System. Invasive hemodynamic assessment (mean pulmonary artery pressure, pulmonary arterial wedge pressure, cardiac output, vascular resistance, right atrial pressure) is performed immediately before and after PFA during the procedure, and repeated approximately 3 months post-procedure. All subjects are followed for 12 months, with structural and functional reassessment by echocardiography, cardiac CT, cardiac MRI, and 14-day Holter monitoring at 3 to 12 months.",[13],"Device: Pulsed-Field Ablation with FARAWAVE Catheter System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Pulsed-Field Ablation with FARAWAVE Catheter System","Pulsed-field ablation is performed using the FARAWAVE \u002F FARADRIVE Catheter and FARASTAR System (Boston Scientific) under deep sedation or general anesthesia. PFA is delivered to achieve pulmonary vein isolation and posterior wall isolation, with additional substrate modification at the operator's discretion. Invasive hemodynamic assessment is performed pre- and post-PFA during the index procedure and repeated at approximately 3 months.",[9],[21,22,23,24],"FARAWAVE Catheter","FARADRIVE Catheter","FARASTAR System","FARAPULSE PFA System",null,[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Fa-Po Dr. Chung, MD, PhD","CONTACT","886-2-28712121","89163","marxtaiji@gmail.com",{"name":34,"role":29,"phone":30,"phoneExt":31,"email":35},"Dr. Chiang, PhD","qqsnoopy0223@gmail.com",[37],{"facility":38,"status":25,"city":39,"state":25,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Taipei Veterans General Hospital","Taipei","112","Taiwan","TW",{"type":44,"coordinates":45},"Point",[46,47],121.52639,25.05306,{"lat":47,"lon":46},[50,51,52],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},{"name":34,"role":29,"phone":30,"phoneExt":31,"email":35},{"name":53,"role":54,"phone":25,"phoneExt":25,"email":25},"Fa-Po Chung, MD, PhD","PRINCIPAL_INVESTIGATOR",{"type":56,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[58],{"name":59,"class":60},"Boston Scientific Corporation","INDUSTRY","100644942","atrial-remodeling-after-pfa-substrate-modification-for-persistent-af-peaf-100644942",false,"NCT07675395","Atrial Remodeling After PFA Substrate Modification for Persistent AF (PeAF)","Pulsed-Field Ablation for Persistent Atrial Fibrillation: Impact of Atrial Remodeling After Substrate Modification","Inclusion Criteria:\n\n* Diagnosis of persistent atrial fibrillation\n* Left atrial anteroposterior (AP) diameter greater than 4 cm and less than 6 cm\n* Anti-arrhythmic medications (except amiodarone) discontinued for at least 5 half-lives before the procedure\n* No use of beta-blockers or diuretics before or after the ablation procedure\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Paroxysmal atrial fibrillation\n* Previous left atrial surgery or catheter ablation procedure, including left atrial appendage closure\n* Atrial fibrillation due to reversible causes, such as thyroid disorders, acute alcohol intoxication, or other major surgeries within the 90 days preceding the procedure\n* Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, or coronary artery bypass grafting within 90 days of the procedure\n* Known presence of cardiac thrombus\n* Stroke or transient ischemic attack within the last 90 days\n* Any other anatomical or comorbid condition that, in the investigator's opinion, could limit the patient's ability to participate in the clinical trial, comply with follow-up requirements, or impact the scientific validity of the clinical trial results","ALL","18 Years",{"count":71,"type":72},30,"ESTIMATED","INTERVENTIONAL",[75],"NA","Atrial fibrillation (AF) is associated with both electrical and structural remodeling of the left atrium. While successful catheter ablation has been shown to reverse some aspects of atrial remodeling, the impact of pulsed-field ablation (PFA) - a non-thermal ablation technology that selectively targets cardiomyocytes while sparing surrounding structures - on atrial remodeling in patients with persistent AF undergoing extensive substrate modification remains unclear.\n\nThis is a prospective, single-center, single-arm observational study conducted at Taipei Veterans General Hospital. The study will enroll 30 patients with persistent atrial fibrillation who undergo pulmonary vein isolation (PVI) and extensive substrate modification using the FARAWAVE \u002F FARADRIVE Catheter and FARASTAR System.\n\nThe primary objective is to evaluate left atrial structural remodeling following PFA, including changes in LA size, atrial strain, extent of atrial fibrosis, and atrial hemodynamic function. The secondary objective is to assess AF-free survival between 3 and 12 months after the procedure, and its relationship to atrial remodeling. All participants will be followed for 12 months, with an interim analysis conducted once all subjects complete their 6-month follow-up.",[78,79,80,81],"Persistent Atrial Fibrillation","Atrial Fibrillation (AF)","Atrial Remodeling","Pulsed Field Ablation",[81,78,83,80,84,85,86,87],"Atrial Fibrillation","Substrate Modification","Atrial Fibrosis","Cardiac MRI","Posterior Wall Isolation","NOT_YET_RECRUITING","2026-06-30",{"date":91,"type":92},"2026-07-02","ACTUAL",{"date":94,"type":72},"2026-07-01",{"date":96,"type":72},"2028-12-31",{"name":5,"class":6},1]